System for mitral valve repair and replacement

ABSTRACT

Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and/or rotating coupled to a proximal set of arms which are also pivotably and/or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of and claims the benefit of priorityfrom U.S. patent application Ser. No. 15/211,940, filed Jul. 15, 2016,now U.S. Pat. No. 9,770,331, which is a Division of and claims thebenefit of priority from U.S. patent application Ser. No. 13/329,083,filed Dec. 16, 2011, now U.S. Pat. No. 9,421,098, which claims thebenefit of priority of U.S. Prov. Pat App. Nos. 61/460,041 filed Dec.23, 2010 and 61/499,630 filed Jun. 21, 2011, each of which areincorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to medical devices used for therepair of dysfunctional heart valves. More particularly, the presentinvention relates to devices and methods used for the repair and/orreplacement of the mitral valve.

BACKGROUND OF THE INVENTION

Conditions affecting the proper functioning of the mitral valve include,for example, mitral valve regurgitation, mitral valve prolapse andmitral valve stenosis. Mitral valve regurgitation is a disorder of theheart in which the leaflets of the mitral valve fail to coapt intoapposition at peak contraction pressures, resulting in abnormal leakingof blood from the left ventricle into the left atrium. There are anumber of structural factors that may affect the proper closure of themitral valve leaflets. For example, many patients suffering from heartdisease experience dilation of the heart muscle, resulting in anenlarged mitral annulus. Enlargement of the mitral annulus makes itdifficult for the leaflets to coapt during systole. A stretch or tear inthe chordae tendineae, the tendons connecting the papillary muscles tothe inferior side of the mitral valve leaflets, may also affect properclosure of the mitral annulus. A ruptured chordae tendineae, forexample, may cause a valve leaflet to prolapse into the left atrium dueto inadequate tension on the leaflet. Abnormal backflow can also occurwhen the functioning of the papillary muscles is compromised, forexample, due to ischemia. As the left ventricle contracts duringsystole, the affected papillary muscles do not contract sufficiently toeffect proper closure.

Mitral valve prolapse, or when the mitral leaflets bulge abnormally upin to the left atrium, causes irregular behavior of the mitral valve andmay also lead to mitral valve regurgitation. Normal functioning of themitral valve may also be affected by mitral valve stenosis, or anarrowing of the mitral valve orifice, which causes impedance of fillingof the left ventricle in diastole.

Typically, treatment for mitral valve regurgitation has involved theapplication of diuretics and/or vasodilators to reduce the amount ofblood flowing back into the left atrium. Other procedures have involvedsurgical approaches (open and intravascular) for either the repair orreplacement of the valve. For example, typical repair approaches haveinvolved where the leaflets of the valve are either made to cinch orportions of the dilated annulus are resected.

Cinching of the annulus has been accomplished by the implantation ofannular or peri-annular rings which are generally secured to the annulusor surrounding tissue. Other repair procedures have also involvedcinching or clipping of the valve leaflets into partial apposition withone another as well. Alternatively, more invasive procedures haveinvolved the replacement of the entire valve itself where mechanicalvalves or biological tissue are implanted into the heart in place of themitral valve. These are conventionally done through large openthoracotomies and are thus very painful and require long recoveryperiods.

However, with many repair and replacement procedures the durability ofthe devices or improper sizing of annuloplasty rings or replacementvalves may result in additional problems for the patient. Moreover, manyof the repair procedures are highly dependent upon the skill of thecardiac surgeon where poorly or inaccurately placed sutures may affectthe success of procedures.

Mitral valve replacement, compared with aortic valve replacement, posesunique anatomical obstacles, rendering percutaneous mitral valvereplacement significantly more involved and challenging than aortic.First, unlike the relatively symmetric and uniform aortic valve, themitral valve annulus has a non-circular oval or kidney-like shape, andmay be of unpredictable geometry, often times lacking symmetry. Suchunpredictability makes it difficult to design a mitral valve prosthesishaving the ability to conform to the mitral annulus. Lack of a snug fitbetween the leaflets and/or annulus and the prosthesis leaves gapstherein, creating backflow of blood through these gaps. Placement of acylindrical valve prostheses, for example, may leave gaps in commissuralregions of the native valve, potentially resulting in perivalvular leaksin those regions,

In addition to its irregular, unpredictable shape, the mitral valveannulus lacks a significant amount of radial support from surroundingtissue. The aortic valve, for example, is completely surrounded bymuscular tissue, helping to anchor a prosthetic valve by providingnative structural support. The mitral valve, on the other hand, isbounded by muscular tissue on the outer wall only. The inner wall of themitral valve is bounded by only a thin wall of tissue separating themitral valve annulus from the inferior portion of the aortic tract. As aresult, significant radial forces on the mitral annulus, such as thatimparted by expanding stent prostheses, could lead to collapse of theinferior portion of the aortic tract with potentially fatalconsequences.

The chordae tendineae of the left ventricle may also present an obstaclein deploying a mitral valve prosthesis. This is unique to the mitralvalve since aortic valve anatomy does not include chordae. The maze ofchordae in the left ventricle makes navigating and positioning adeployment catheter that much more difficult in mitral valve replacementand repair. Deployment and positioning of a prosthetic valve oranchoring device on the ventricular side of the native valve is alsocomplicated by the presence of the chordae.

Given the difficulties associated with current procedures, there remainsthe need for simple, effective, and less invasive devices and methodsfor treating dysfunctional heart valves.

SUMMARY OF THE INVENTION

An interventional device may be advanced intravascularly into the heartof a patient and deployed upon or along the mitral valve to stabilizethe valve leaflets. The interventional device may also facilitate theplacement or anchoring of a prosthetic mitral valve implant in anefficient manner. The interventional device may generally comprise asubannular set of arms pivotably and/or rotatably coupled to asupra-annular set of arms. The distal set of arms may be advanced pastthe catheter opening to a subannular position (e.g., below the annulusof the mitral valve and behind the native leaflets) and reconfiguredfrom a low-profile delivery configuration to a deployed securementconfiguration. The proximal arm members may then also be deployed suchthat the distal and proximal arm members, once fully deployed, may gripthe leaflets and/or the annulus between the two sets of arms tostabilize the leaflets. In either case, the arm members may be deployedeither sequentially or simultaneously depending upon the desired orderof deployment.

When the proximal and distal stabilizing assemblies are actuated toreconfigure from their axially-elongated low-profile configuration, theassemblies may reconfigure into a deployed expanded configuration wherethe pivoting arrangements of each arm and joining member allows theassemblies to extend radially in a jack-like configuration to a deployedconfiguration. In the deployed configuration, each of the arm membersmay pivot to collapse the arm members in a radial direction relative toa longitudinal axis of the assembly against the side surfaces of anadjacent arm member assembly such that the resulting deployed shape ofthe arm members may form a curved or partially curved configurationwhich may follow along a periphery of the mitral valve.

In one example for delivering and deploying one or more interventionaldevices, the devices may be deployed from a supra-annular approach fromwithin left atrium of the heart H or from a subannular approach fromwithin the left ventricle. Moreover, one or more interventional devicesmay be deployed in or near one or both valve commissures with thedeployed arm members compressing the leaflets therebetween, stabilizinga portion of the valve leaflets while allowing the remainder of theleaflet(s) to move in an uninhibited fashion. While the one or moreinterventional devices may be utilized alone, a stent, scaffold, orreplacement valve assembly may optionally used as well in combinationwith the one or more assemblies. The valve assembly may be expanded andoptionally anchored to the stabilizing assemblies such that the valveassembly extends above, below, or entirely through the mitral valve.

Once the interventional device has been delivered and/or expanded intoits deployed configuration, the device may be locked into its deployedshape and left implanted upon or along the mitral valve. To ensure thatthe device remains secured upon the valve leaflets, various lockingmechanisms may be incorporated into the device. For example variouslocking mechanisms such as, e.g., screw threads, gripping element with arelease wire, or other suitable attachment mechanisms may be used.

In yet another variation, one or more of the arm members themselves maybe formed of multiple links or segments which increase the flexibilityof the device. The arm members formed of the links or segments mayprovide for increased flexibility of the assemblies when placed againstthe leaflets. Having the increased flexibility may allow for theinterventional device to more closely conform to a particular anatomy ofa valve and may further provide for enhanced support of the valve.

Additionally and/or alternatively, one or all of the arm members mayhave rounded or curved edges to facilitate delivery of the devicethrough the catheter as well as to reduce any potential wear against theinternal catheter surface. For example, if a delivery catheter having a6 mm internal diameter, each respective arm member may have a crosssectional width, e.g., of about 5 mm and a height, e.g., of about 2 mm.Having the curved edges may allow for the translation of the devicethrough the catheter lumen without wearing along the lumen surfaces.Moreover, the curved surfaces and edges of each arm member may alsoreduce any potential wear on the contacted mitral leaflets as well.

In any of the variations of the interventional devices described herein,various features or projections such as pins, castellations, raisedtabs, or any other projections, protrusions, bumps, or features whichmay facilitate engagement with a replacement mitral valve implant may beformed along one or more arm members. These features may be locatedalong the surface of the arm members which face the central region ofthe mitral valve when deployed.

Additionally and/or alternatively, these various features or projectionsmay also be defined along the surfaces of the arm members which comeinto direct contact against the mitral valve leaflets. For example, thearm members of both proximal and distal stabilizing assemblies whichextend into contact against the surfaces of the mitral leaflets may alsoincorporate various features. Examples shown may include projections,tabs, or pins which may simply compress upon the opposed surfaces of themitral leaflets or they may be correspondingly designed to interdigitateor lock in an alternating pattern with respect to opposed features orprojections when brought down upon the mitral leaflets into a lockingconfiguration. Moreover, such features or projections may be covered bya fabric or covering, such as a knitted sleeve, to present a relativelyatraumatic surface.

In yet another variation, the arm members may be further varied byincorporating narrowed or tapered arms that may reduce any risk ofperivalvular leakage in the space between the arms, if any.Alternatively, the stabilizing assemblies may incorporate narrowed ortapered arms which die directly into the posterior wall of the mitralvalve such that any replacement valve may directly contact against theposterior wall without any gaps.

Another variation of the arm members may incorporate extensions whichmay extend linearly out or may fold out from the posterior set of armsto fill in any gaps along the posterior leaflet. The extensions mayoptionally extend partially or may lock with respect to an apposedextension. Yet another variation may incorporate a coupling mechanismsuch as a sliding suture lock which may be advanced over wires orsutures extending from the arms of multiple assemblies to create a rigidor secure connection between each of the implanted assemblies in theirdeployed configurations upon the valve leaflets.

Yet another variation may include arm members which may be configured inan alternative arrangement where the distal stabilizing structure may beconfigured to have deployed arm members which are relatively shorterthan the deployed arm members of the proximal stabilizing structure tofacilitate deployment of the distal stabilizing structure withoutinterfering with the chordae tendineae or papillary muscles found withinthe left ventricle. The lengths of the shortened distal stabilizing armmembers may vary along any range and may also be configured to berelatively longer than the arms of the proximal stabilizing structure inyet other variations.

With respect to locking mechanisms, various types of mechanisms may beutilized to lock the interventional device into its deployedconfiguration. The interventional device may incorporate one or morerespective locking mechanisms (e.g., pins, ratchets, crimps, collars,threaded fasteners, rivets, knotted tensioning loops, etc.) positionedalong a side surface of the arm members such that the locking mechanismsare received into respective receiving channels defined along apposedarm members when reconfigured into the deployed configuration. Aspreviously described, a tensioning wire, suture, or catheter may becoupled to a distal end of the interventional device such that whentensioned, the device may reconfigure into a laterally-elongated,deployed configuration. Also, as the arm members fold into theirdeployed shape, the locking mechanisms may be received into theirrespective receiving channels and locked automatically to secure the armmembers into their deployed configurations.

In yet additional variations, rather than the proximal interventionaldevice being modified, the distal interventional device may be modifiedas well. One variation may include a telescoping assembly which may bedeployable in the sub-annular space below the plane upon the ventricularside of the mitral valve. The telescoping assembly may be comprised oftelescoping arms which are attached to a pivoting assembly which may beused to position the arms from a low-profile extended configuration toan angled deployed configuration. Once positioned for extension, one ormore telescoping members may extend linearly at an angle relative to oneanother (acute, right, or obtuse depending upon the desiredconfiguration) from each arm. Alternatively, the telescoping members mayextend in a curved or arcuate manner to form curved arm member whendeployed. In yet another configuration, one telescoping arm may extendlinearly while the opposite arm extends to form a curved deployed arm.Having the arms telescope outward may avoid entanglement with variousventricular obstructions such as the chordae tendineae and/or papillarymuscles. With the arms fully extended, the proximal stabilizingstructure may then be deployed for securement upon the upper leafletsurfaces.

Another variation may also utilize two or more arms which may projectlinearly from a catheter and extend perpendicularly or at an anglerelative to the catheter to form a curved arm along a supravalvularposition upon the upper leaflet surface or surfaces as well as along asubvalvular position along a lower leaflet surface or surfaces.Alternatively and/or additionally, the arms may be advanced forpositioning upon or adjacent to the anterior and posterior annulus.

The two or more arms may project through corresponding openings whichare adjacently positioned along the catheter and in one variation, twoproximal arms may extend from the catheter along a supravalvularposition while two additional distal arms may extend from the catheteralong a subvalvular position to at least partially compress or stabilizethe valve leaflets between the proximal and distal pair of arms.

After locating or situating the assembly at the level of one or bothmitral commissures or in other gaps between the segments of the mitralleaflets, the assembly provides the passage of supravalvular arms andsubvalvular arms which may be placed at least partially or completelycircumferentially above and below the anterior and posterior annulus orupon the valve leaflets. The apparatus may then be used to provide aplatform for the placement and fixation of existing transcatheter andsutureless valve prostheses.

The arms may be constructed from various biocompatible materialssufficient to provide flexibility yet are rigid or semi-rigid enough toprovide support to the valve leaflets, e.g., shape memory alloys,stainless steels, etc. Alternatively, the arm members may be constructedso as to form inflatable tubular structures that may have rigidityinduced by an inflation gas, fluid, or other medium (e.g., saline,water, etc.) introduced into the arm structures at a sufficiently highpressure. Alternatively, the rigidity along the arm members may beinduced by inflating the arms with a hardening fluid which is liquidwhen introduced but which hardens or solidifies after filling the armmembers. Additionally and/or alternatively, the arm members may have anynumber of frictional components or projections (barbs, spikes, etc., orany of the projections or elements described herein) formed upon thecontact surfaces of the arm members to increase the fixation between thearms and the underlying tissue.

Moreover, the length of the arm members may be varied to extend aboutthe periphery of the valve annulus partially or entirely around theperiphery to overlap upon themselves. Alternatively, a second assemblymay be used in combination with a first assembly such that each assemblyis positioned and deployed at opposed ends of the valve. Each of theassemblies may have their arm members extended towards one another toincrease annular rigidity.

In yet another variation of the interventional device, a supporting ringmay be utilized in combination with one or more retaining members ratherthan with a interventional device. A prosthetic supra-annular ring maybe shaped or sized similarly to a periphery of the mitral valve and mayalso support an implanted prosthetic valve. One or more openings mayalso be defined at either end of the ring along the circumference toprovide guidance for wire or sutures which may pass through eachrespective opening. The couplings may be attached to respective wire orsuture such that the couplings may be received within the respectiveopenings defined through the ring in a locking manner when each wire orsuture is tensioned to secure a position of each respective retainermember relative to the ring. The couplings may define one or moretapered members which allow for their insertion into and/or through theopenings which inhibit their retraction or withdrawal to allow foradjustable securement of the ring and retainer members upon the mitralvalve annulus. Alternatively, various other mechanisms such asratcheting teeth, pawls, spherical locking elements, hitch/ringassembly, etc. may be used.

Another variation of the interventional devices(s) include at least twoindependently deployable structures positionable in a sub-annular spaceand configured to engage a subannular surface of the mitral valve whendeployed. The independently deployable structures may be positioned atany point along the annulus, e.g. on opposing sides of the valve, in thevalve commissures, etc. Likewise, the at least two independentlydeployable structures may be interconnected, as described herein.Furthermore, the device may include a prosthetic valve coupleable to theat least two independently deployable structures.

The interventional device(s) may also comprise a stabilizing structuremovable between a first configuration and a second configuration. In thefirst configuration the stabilizing structure(s) are positionablebetween the leaflets. The first configuration may assume a variety offorms, including, for example, a flexible, linear configuration and/oran axially-elongated configuration. In the first configuration thestabilizing structure(s) may be positionable between the leaflets of themitral valve into a subannular space. In the second configuration, thestabilizing structure is configured to engage a ventricular surface ofthe valve and/or leaflets. Like the first configuration, the secondconfiguration may assume a variety of forms, including a curvedconfiguration which may approximate the shape of the native valveannulus. Furthermore, the device may include a prosthetic valvecoupleable to the at least two independently deployable structures.

The device may also include a first and second stabilizing structurepositionable in a subannular space of the heart valve. A prostheticvalve may be coupleable to the stabilizing structures.

In yet another variation, the interventional devices(s) may include afirst portion of the device which is positionable in a subannular spaceas well as a second portion of the device positionable in asupra-annular space. The first portion may also include two laterallyextending wings positionable in the subannular space, where thelaterally extending wings are capable of collapsing to a linear,flexible configuration and also a laterally-elongated, rigidconfiguration. Furthermore, the first portion and second portion maycompress a mitral leaflet(s) and/or annulus therebetween. The secondportion may be detachable from the first portion. In addition, aflexible tether may be coupled to the first or subannular portion of thedevice. Likewise, the device may include a coupling mechanism forcoupling the first portion to the second portion at the native valvesite when the second portion is positioned in the subannular space.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 shows a perspective view of one variation of a catheter assemblyfor intravascularly delivering and deploying an interventional device.

FIGS. 2A and 2B show front and side views, respectively, of onevariation of an interventional device in its low-profileaxially-elongated delivery configuration.

FIG. 2C shows a perspective view of the interventional device in apartially expanded configuration where a proximal stabilizing structureand a distal stabilizing structure are partially reconfigured.

FIG. 2D shows a side view of the interventional device in its deployedconfiguration for placement along and upon the valve.

FIGS. 3A to 3D illustrate front and perspective views of anothervariation of the interventional device incorporating extension membersoptionally having an engagement feature defined along the extensionmember for adjustable securement with a corresponding extension member.

FIGS. 4A and 4B illustrate perspective and side views of anothervariation of a interventional device having arm members which are formedof segments or links which provide increased flexibility for conformingagainst the anatomy of the valve.

FIGS. 5A to 5C illustrate variations of the segmented or linked armmembers which may be tensioned into a predefined curvature or shape.

FIG. 6 shows a perspective views of yet another variation of segmentedor linked arm members which may be coupled via pivots.

FIGS. 7A and 7B show perspective views of yet another variation ofsegmented or linked arm members which may be formed into a singleundulating pattern.

FIG. 8 illustrates an end view of arm members which may be formed tohave curved or rounded edges to facilitate deployment from the catheteras well as reduce any potential wear against tissue.

FIGS. 9A to 9C illustrate front, side, and perspective views of anothervariation of the interventional device having the one or more featuresformed upon the respective arm members for contacting against theleaflets.

FIGS. 10A to 10C illustrate partial cross-sectional side views of thereconfigured interventional device having one or more various featuresupon the arm members for adhering against the leaflets.

FIGS. 11A and 11B illustrate top views of variations where the armmembers may be configured to be tapered or narrowed for minimizinginterference with the leaflets.

FIG. 11C illustrates a top view of another variation where the armmembers may include extensions for providing additional stabilization tothe leaflets or where the interventional devices may be secured to oneanother for further stabilizing the leaflets.

FIGS. 12A and 12B illustrate perspective and side views of anothervariation where the distal stabilizing structure may be formed to havearm members which are relatively shorter than the arm members of theproximal stabilizing structure when in their deployed configurations.

FIGS. 13A to 13C illustrate perspective and side views of anothervariation where the distal and proximal stabilizing assemblies may bestaggered with respect to one another in their deployed configurationsto increase the stabilizing surface area against the leaflets or toprovide for further securement of the leaflets.

FIGS. 14A to 14C illustrate perspective views of another variation of aninterventional device which may incorporate telescoping arm members fordeployment along the subannular surface.

FIGS. 15A to 15C illustrate top and end views of another variation oftelescoping arm members which may configure into curved arm members.

FIGS. 15D and 15E illustrate a perspective view of another variation ofa device having two or more arms which may project perpendicularly or atan angle relative to a catheter for capturing a valve annulus orleaflets between the arm members.

FIG. 15F illustrates another variation where the subvalvularlypositioned arms may be configured to extend from an inner catheter whichis translatable relative to an outer catheter to facilitate compressionof the tissue between the extended arm members.

FIGS. 16A to 16B illustrate a perspective view of another variationwhere the hinge member may be positioned along a side of the arm membersaway from the valve annulus when deployed.

FIGS. 17A to 17E illustrate side views of another variation where theproximal and distal stabilizing structures may be deployed andreconfigured in sequence.

FIGS. 18A to 18F illustrate perspective views of one example where afirst interventional device may be deployed and secured at a first endof the mitral valve and where a second interventional device may bedeployed and secured at a second end of the mitral valve such that eachinterventional device may curve around a periphery of the valve.

FIGS. 19A and 19B illustrate top views of a defective mitral valve wherethe posterior and anterior mitral leaflets fail to coapt and how theinterventional devices may be positioned along the leaflets at opposedends of the valve to facilitate coaptation of the leaflets.

FIG. 20A illustrates an anatomical view of the thin vessel wallsurrounding the anterior mitral leaflet.

FIG. 20B illustrates an anatomical view of placement of a valve assemblyutilizing one interventional device along the anterior leaflet.

FIGS. 21A to 21C illustrate side and perspective views of aninterventional device having a respective extension member.

FIGS. 22A to 22F illustrate perspective views of one or moreinterventional devices having a respective extension member deployedupon a valve into locking engagement with one another.

FIGS. 23A and 23B illustrate front and perspective views of anothervariation where the interventional device may incorporate curvedstabilizing arms which may extend over the leaflet into securement withone another.

FIG. 23C illustrates a top view of an interventional device with curvedstabilizing arms.

FIG. 24A illustrates the catheter assembly of FIGS. 15D and 15Epositioned within a valve, such as a mitral valve, with the arm membersextended and compressed upon the annular and/or leaflet tissue.

FIGS. 24B and 24C illustrate partial cross-sectional side views of thecatheter assembly deploying the arm members and detaching from theassembly and securing a prosthesis to the arm members and through thevalve.

FIG. 24D illustrates a perspective view of an additional catheterassembly deployed in apposition to a first assembly.

FIGS. 25 to 27 illustrate side, detail, and partial cross-sectional sideviews of another variation of an interventional device which may bereconfigured and locked into its deployed configuration using variouslocking mechanisms such as a threaded collar.

FIG. 28 illustrates a front view of another variation where the armmembers may incorporate locking features extending from a first set ofarms for engagement with a second set of arms for securing the device inits deployed configuration.

FIGS. 29A to 30 illustrate partial cross-sectional side views ofratcheting locking mechanisms which may be utilized to lock theinterventional device.

FIGS. 30A to 31B illustrate partial cross-sectional side views of otherexamples of crimped locking mechanisms which may be utilized to lock theinterventional device.

FIGS. 32A to 32C illustrate cross-sectional side views of anotherlocking mechanism where the locking member may be tensioned to hold theinterventional device into its laterally-elongated configuration.

FIGS. 33A to 33C illustrate partial cross-sectional side views ofanother variation where the locking mechanism may incorporate a pin forlocking partially or entirely through a slotted receiving channel.

FIG. 34 illustrates a partial cross-sectional side view of anothervariation of a locking mechanism which utilizes a threaded member forsecuring the interventional device.

FIGS. 35A and 35B illustrate partial cross-sectional side views ofanother variation where a deformable rivet may be used as a lockingmechanism.

FIGS. 36A and 36B illustrate front and detail front views of anothervariation of a locking mechanism where a wire or suture may be passedthrough the interventional device and adjustably secured between thehinges or engagement links

FIG. 37 illustrates a top view of another variation of a lockingmechanism where a loop slides over adjacent links to lock the structuresin place.

FIG. 38A to 38B illustrates a perspective view of another variationwhere a scaffold or implant valve assembly may be integrated with theone or more interventional devices.

FIG. 39 illustrates a side view of a locking mechanism for attaching thevalve assembly.

FIGS. 40A to 40B illustrate top and perspective views of variations ofrings which may be secured upon the one or more interventional devices.

FIGS. 41A to 41D illustrate perspective and tops views of othervariations where the one or more interventional devices may incorporatea reinforcement ring.

FIGS. 42A and 42B illustrate perspective views of variations of ringsfurther incorporating projections or engagement mechanisms forsecurement to the leaflets or surrounding annulus.

FIGS. 43A to 43C illustrate side and perspective views of anothervariation of an interventional device utilizing one or more subannularstabilizing members with a supra-annular ring.

FIGS. 44A to 44F illustrate an example for deploying the subannularstabilizing members and supra-annular ring upon a mitral valve.

FIGS. 45A to 45E illustrate another variation of an interventionaldevice utilizing a distal stabilizing structure with a supra-annularring

FIGS. 46A and 46B illustrate perspective views of various examples offeatures, such as pins, castellations, projections, tabs, etc. which maybe formed upon the arm members of the interventional device for contactagainst the leaflet or tissue surfaces or for securing an implantedinterventional device.

FIGS. 47A to 47F illustrate partial cross-sectional side views of aheart where a catheter assembly may be advanced intravascularly throughan inferior vena cava and transseptally into a left atrium of a patientand into proximity to the mitral valve.

FIGS. 47G to 47J illustrate partial cross-sectional side views where oneor more interventional devices may be deployed from a supra-annularapproach and reconfigured upon the mitral valve leaflets.

FIG. 47K illustrates how a replacement valve assembly may be optionallydelivered and secured to the interventional devices.

FIGS. 48A to 48D illustrate partial cross-sectional side views ofanother example where a catheter assembly may be advancedintravascularly through an aortic valve and into a left ventricle of apatient.

FIGS. 48E to 48I illustrate how one or more interventional devices maybe deployed from an subannular approach and reconfigured upon the mitralvalve leaflets with an optional replacement valve assembly.

DETAILED DESCRIPTION OF THE INVENTION

In repairing and/or replacing a defective heart valve, such as a mitralvalve, an interventional device may be advanced intravascularly into theheart of a patient and deployed upon or along the mitral valve to affectthe abnormal functioning of the valve leaflets. The interventionaldevice may also facilitate the placement or anchoring of a prostheticmitral valve implant in an efficient manner. In one variation, theinterventional device may generally comprise a distal stabilizingstructure 14 pivotably and/or rotatably coupled to a proximalstabilizing structure 12. The distal stabilizing structure 14 may beadvanced past the catheter opening, through the mitral annulus, andreconfigured from a low-profile, axially-elongated deliveryconfiguration, as shown in FIG. 2A, to a laterally-elongated deployedconfiguration, as shown in FIG. 2C. Deployment of the distal stabilizingstructure may result from the urging of a biasing element, such as atorsion spring, and/or the tensioning of a control member such as asuture or wire. The proximal stabilizing structure 12 may also bedeployed, either sequentially (as shown in FIGS. 18A-18F) orsimultaneously with the distal stabilizing structure 14 (as shown inFIG. 1C), such that the distal and proximal stabilizing structures 12,14 may grip the leaflets and/or annulus between the two valve assemblies12, 14 in order to stabilize the leaflets and/or to provide a stableplatform to which a prosthetic valve may be anchored.

As used herein, the terms “distal” and “proximal” are relative to thecatheter assembly 2 along the axis of the catheter assembly 2. Forexample, the distal end of the guidewire 9 is farther from the handle 4of the catheter assembly 2 and the proximal end of the guidewire 9 isthe portion of the guidewire 9 closer to the handle 4 of the catheterassembly 2.

As used herein, “stabilizing structure” may refer to a structure placedabove, below, along, or within the annulus, and may take a conformationencompassing the entire circumference of the annulus or a partialcircumference of the annulus.

As used herein, depending on the intravascular approach utilized (e.g.,retrograde, antegrade, etc.) the distal and proximal stabilizingstructures may have varying orientations with respect to the mitralvalve annulus. For example, the distal stabilizing structure may bepositioned supra-annularly if the retrograde approach is utilized or maybe positioned subannularly if the antegrade approach is utilized.Likewise, the proximal stabilizing structure may be positionedsubannularly if the retrograde approach is utilized or may be positionedsupra-annularly if the antegrade approach is utilized.

I. Device Embodiments

FIG. 1 illustrates a perspective view of one variation of a deploymentcatheter assembly 2 which may be used to intravascularly deliver anddeploy the interventional device. Generally, the catheter assembly 2 maycomprise a handle 4 which is coupled to a proximal end of a cathetershaft 6, e.g., 18F-20F diameter. Catheter shaft may include at least onecatheter port(s) 5. A distal end 7 of the catheter may define an openingthrough which a guidewire 9 may be passed as well as a delivery shaft 6which may be coupled to the interventional device for delivery and/ordeployment from the catheter.

FIGS. 2A and 2B show the top and side views of one variation of theinterventional device 10. The interventional device 10 may generallycomprise a distal stabilizing structure 14 pivotably and/or rotatablycoupled to a proximal stabilizing structure 12. In this variation, theproximal and distal stabilizing structures 12, 14 are illustrated ashaving similar or equal lengths although the respective lengths may bevaried to be non-uniform depending upon the desired deployedconfiguration, as further described below.

FIGS. 2A and 2B show the interventional device 10 in a low-profiledelivery configuration for storage and delivery from a catheter lumen.When the interventional device 10 is in its delivery configuration, bothfirst and second stabilizing assemblies 12, 14 are in theiraxially-elongated configurations.

In the deployed configuration, each of the arm members may pivot tocollapse the arm members in a lateral direction relative to alongitudinal axis of the assembly 10. Arm members may collapse againstthe side surfaces of adjacent arm members such that the resultinglaterally-elongated shape of the arm members may form a curved orpartially curved configuration which may follow along a periphery of themitral valve annulus. For example, the deployed arm members may beformed to extend over a 60° span. In this variation, deployment of theinterventional device 10 transforms the arm members from a flexiblelinear arrangement into a rigid arc of fixed radius.

FIG. 2C shows one variation of the device in one variation of anintermediate configuration, or between the axially-elongated andlaterally-elongated configurations. When the first and secondstabilizing assemblies 12, 14 reconfigure from their axially-elongatedconfigurations to their deployed laterally-elongated configurations, thepivoting arrangements of each arm member and joining member allows thearms and joining members to extend laterally in a jack-like fashion, asshown in the perspective view of FIG. 2C. The distal 14 and proximal 12stabilizing structures may transform from the laterally-elongatedconfiguration to the axially-elongated configuration independently,dependently, sequentially, simultaneously or any combination thereof.FIG. 2D shows the interventional device 10 in its deployedconfiguration, wherein both the proximal and distal stabilizingstructures 12, 14 are in a laterally-elongated configuration.

The proximal stabilizing structure 12 may be comprised of a first pairof arm members 16A. 168 which are pivotably joined to a proximalengagement link 32 at a first end through joints ISA, 15B, and alsopivotably joined to respective joining members 18A, 18B at a second endthrough joints 17A, 17B. While the first pair of arm members 16A, 16Bmay pivot around joints ISA. 15B within a first plane parallel to thebroad face of link 32, the coupling at the second end may pivot aroundjoints 17A, 17B within a second plane parallel to the broad face of thesuperior portion of arms 16A, 16B, which can be transverse (FIG. 2D) orangled (e.g., FIG. 2C) relative to the first plane. The joining members18A, 18B may be further pivotably coupled to a first end of a secondpair of arms 20A, 20B via respective links 34A, 34B which allow forpivotable movement in a third plane parallel to the broad face of links34A, 34B. The second pair of arms 20A, 20B may be further coupledpivotably to joining members 22A, 22B such that the pivotable movementof the second ends of the second pair of arms 20A, 20B may occur aroundrespective joints 21A, 21B within a fourth plane parallel to thesuperior portion of arms 20A, 20B. Joining members 22A, 22B may then bepivotably coupled to a middle engagement link 36 such that the pivotablemovement of the second ends of the joining members 22A, 22B may occuraround link 36 within a fifth plane parallel to the broad face of link36.

The distal stabilizing structure 14 may be coupled similarly to theproximal stabilizing structure 12 where joining members 24A. 24B may bepivotably coupled to the middle engagement link 36 such that thepivotable movement of the joining members 24A, 24B may occur around link36 within the fifth plane. Joining members 24A. 24B may be furtherpivotably coupled to a first end of a third pair of arms 26A, 26B suchthat the pivotable movement of the arms 26A, 26B may occur around joints25A, 25B within a sixth plane parallel to the broad face of the superiorportions of arms 26A, 26B. The second ends of arms 26A, 26B may bepivotably coupled to joining members 28A, 28B via links 38A, 38B wherepivoting movement may occur within a seventh plane parallel to the broadface of links 38A, 38B. A first end of a fourth pair of arms 30A, 30Bmay be pivotably coupled to the joining members 28A, 28B aroundrespective joints 29A, 29R, such that the pivotable movement of thefirst end of arms 30A, 30B is within an eighth plane parallel to theinferior faces of joining members 28A, 28B. The second end of each arm30A, 30B may be pivotably coupled to distal engagement link 40 in apivoting engagement which allows for pivoting motion around respectivejoints 31A, 31B within a ninth plane parallel to the broad face of link40.

There are several advantages to utilization of multi-arm, multi-linkassemblies. First, multi-arm, multi-link assembly provides for multipleplanes of pivotal movement around multiple axes of rotation, allowinggreater manipulation of the profile and shape of the interventionaldevice 10, both in its delivery and deployed configuration. Theflexibility of the interventional device 10 presents an advantage inthat it may assume a linear, low-profile delivery configuration, shown,for example, in FIG. 2A, while remaining flexible enough to bend alongthe catheter lumen during delivery and/or deployment. Despite theflexibility of the interventional device 10, however, the presence ofmultiple links and arms also provides substantial rigidity once theinterventional device 10 is in the fully deployed configuration, whereeach assembly is in its laterally-elongated configuration. Such rigiditymay be provided by the offsetting of the arms and joining members withineach layer of each annular structure. For example, in FIG. 2Ddistribution of arms and joining members is such that, once the distalstabilizing structure 14 is in the laterally-elongated configuration,first pair of arms 16A, 16B are no longer able to rotate around, forexample, respective joints 17A, 17B since first pair of arms 16A, 16Bstraddles respective joints 21A, 21B. This is but one example of theinterlocking mechanisms employed by the multi-arm, multi-link structureof each annular structure.

Each of the arm members and joining members may be made from any numberof suitable biocompatible materials, e.g., stainless steel, variouspolymers, ELGILOY® (Elgin, Ill.), pyrolytic carbon, silicone,polytetrafluoroethylene (PTFE), or any number of other materials orcombination of materials depending upon the desired results. The armmembers may also be coated or covered with a material that promotestissue in-growth, e.g., Dacron, PTFE, etc.

FIGS. 3A-3D illustrate another variation of the interventional device,where the arm and joining arm members have a more consistently arcuateshape along its periphery than the arms and joining members ofinterventional device 10. Interventional device 80 where each of theproximal and distal stabilizing structures 82, 84 may be formed of afirst pair of arms 54A, 54B and joining members 56A, 56B and a secondpair of arms 58A, 58B and joining members 60A, 60B each pivotablyjoined, as previously described, but where the arm members form a moreuniform and curvilinear shape. Similarly, the distal stabilizingstructure 84 may be coupled via a middle link and is formed of joiningmembers 62A, 62B and a third pair of arms 64A, 64B and further byjoining members 66A, 66B and a fourth pair of arms 68A, 68B eachpivotably joined to one another. FIGS. 3C and 3D illustrate how thefirst and second assemblies 82, 84 may pivot along their respectivelinks and pivoted connections to expand into a laterally-elongatedconfiguration, shown in FIG. 3D.

In yet another variation, one or more the arm members themselves may beformed of multiple links or segments coupled together in such a way soas to increase a flexibility of the assembly. An example is illustratedin the perspective and side views of FIGS. 4A and 4B. As shown, aninterventional device 140 may have a proximal stabilizing structure 142and a distal stabilizing structure 144 where at least some of therespective arm members are comprised of multiple small links or segments146 linked together by flexible elongate couplings. The arm membersformed of the links or segments 146 may provide for increasedflexibility of the assemblies when placed against the leaflets. Havingthe increased flexibility may allow for the interventional device tomore closely conform to a particular anatomy of a valve and may furtherprovide for enhanced support of the valve and may require less clearancewithin the heart chambers for deployment.

In other variations where the arm members are comprised of segmentedarms, one or more of the arm members may have links or segments 150which may become rigid by the tensioning of a pullwire 152 to maintain aparticular shape of the arm member. As illustrated in the example ofFIG. 5A, a pullwire 152 may extend through each of the links such thatwhen tensioned the arm member may become rigid as the links 150 compressagainst one another and when released, allows the arm member to becomeflexible, as shown in FIG. 58B. Alternatively and/or additionally, theinterfacing ends of the links or segments 154 may be preformed to havevarious angles or shapes such that when tensioned by pullwire 152, thearm member assumes a predetermined shape, as shown in FIG. 5C.

In yet other variations with segmented arm members, one or more of thearm members may be formed as links or segments 160 coupled via slottedconnections 162 which are rotatably hinged 164 to allow for bending in asingle plane but provides for stiffness in a transverse plane, as shownin FIG. 6. Alternatively, the links or segments 160 may be hinged in analternating manner to allow for differential bending of the structure.Yet another variation is shown in the perspective view of FIG. 7A whichillustrates an arm member which is formed of a patterned member 166 suchas an undulating pattern formed by molded or machined portions 168removed from the arm member. Such a configuration may also allow fordifferential bending of the structure such that flexibility against aleaflet surface may be provided while maintaining a degree of structuralstiffness along another plane. A pullwire 152 may be passed through alumen extending through the length of the arm member such that bytensioning the wire 152 the arm member will bend into a desired shape,as shown in FIG. 7B.

Additionally and/or alternatively, one or all of the arm members mayhave rounded or curved edges 170, as shown in the end view of FIG. 8, tofacilitate delivery of the assembly through catheter 54 as well as toreduce any potential wear against the internal catheter surface orinjury to valve tissue. For example, if a delivery catheter having a 6mm internal diameter, each respective arm member may have a crosssectional width, e.g., of about 5 mm and a height, e.g., of about 2 mm.Having the curved edges 170 may allow for the translation of theassembly through the catheter lumen without wearing along the lumensurfaces. Moreover, the curved surfaces and edges of each arm member mayalso reduce any potential wear on the contacted mitral leaflets as well.

In any of the variations of the interventional devices described herein,various features or projections such as pins 190, castellations 192,raised tabs 194, or any other projections, protrusions, bumps 196, orfeatures which may facilitate engagement with a replacement mitral valveimplant may be formed along one or more arm members, for example alongthe surface of the arm members which face the central region of themitral valve when deployed as shown in FIGS. 9A to 9C. Additionallyand/or alternatively, these various features may additionally oralternatively be defined along the surfaces of the arm members whichcome into direct contact against the mitral valve leaflets. For example,as shown in the cross-sectional side view of FIGS. 10A to 10C, the armmembers of both proximal and distal stabilizing structures 12, 14 whichextend into contact against the surfaces of the mitral leaflets may alsoincorporate various features. Examples shown may include projections190, tabs 192, or pins 194 which may simply compress upon the opposedsurfaces of the mitral leaflets or they may be correspondingly designedto interdigitate or lock in an alternating pattern with respect toopposed features or projections when brought down upon the mitralleaflets into a locking configuration. Moreover, such features orprojections may be covered by a fabric or covering, such as a knittedsleeve, to present a relatively atraumatic surface.

In yet another variation, the arm members may be further varied byincorporating narrowed or tapered arms 200 that may reduce any risk ofperivalvular leakage in the space between the arms, if any, as shown inthe top view of FIG. 11A. Alternatively, the stabilizing assemblies mayincorporate narrowed or tapered arms 202 which taper or narrow to apoint as they approach the posterior wall 203 of the mitral valve MVsuch that any replacement valve may directly contact against theposterior wall 203 without any gaps, as shown in FIG. 11B.

FIG. 11C shows a top view of another variation where the arm members mayincorporate extensions 204 which may extend linearly or may fold outfrom the posterior set of arms to fill in any gaps along the posteriorleaflet PML. The extensions 204 may optionally extend partially or maylock with respect to an apposed extension 204, as described in furtherdetail below.

FIGS. 12A and 12B show perspective and front views of yet anothervariation where the arm members may be configured in an alternativearrangement. In this variation, the supra-annular structure 212 may beconfigured to have deployed arm members which are relatively shorterthan the deployed arm members of the proximal stabilizing structure 210to facilitate deployment of the subannular assembly 212 withoutinterfering with the chordae tendineae CT, or papillary muscles PM orwall of the left ventricle. The lengths of the shortened subannular armmembers may vary along any range and may also be configured to berelatively longer than the arms of the supra-annular assembly 210 in yetother variations the supra-annular arms may be long enough to completelyencircle the valve.

FIGS. 13A to 13C illustrate perspective and cross-sectional side viewsof additional variations in the arm member configuration. As shown inFIG. 13A, the individual arm members may configured such that thesubannular and supra-annular assemblies 12, 14 are radially offset insuch a way that the subannular arm members are positioned towards thecenter of the valve orifice, further than the supra-annular arm members,such that the effective width of the combined arm members covers alarger area of the valve leaflets which moves the leaflet hinge pointfurther toward the center of the valve orifice and limits the upwardsbillowing of the leaflets, e.g., during systole, to improve the abilityof the leaflets to close effectively.

FIGS. 13B and 13C illustrate cross-sectional side views where the armmembers of the supra-annular structure 12 are positioned further awayfrom the center of the valve orifice (in an opposite direction from thatshown in FIG. 13A). In this variation, the arm members of thesupra-annular structure 12 may be substantially adjacent to (as shown inFIG. 13B) or may just extend beyond (as shown in FIG. 13C) or mayoverlap slightly with the arm members of the subannular structure 14.Such an arrangement increases the area of contact with the leaflets andmay help to ensure the securement of the assembly to the leaflets. Inaddition, as shown in FIG. 13C, where the subannular structure isfurther offset from the supra-annular as to have a gap disposed radiallybetween them, the leaflet may be folded or crimped through the gap so asto further enhance the grip on the leaflets.

In yet additional variations, rather than the proximal interventionaldevice being modified, the distal interventional device may be modified.One variation is shown in the perspective views of FIGS. 14A to 14Cwhich illustrate a telescoping assembly 230 which may be deployable inthe sub-annular space below the plane upon the ventricular side of themitral valve MV. The telescoping assembly 230 may be comprised oftelescoping arms 232A, 232B which are attached to a pivoting assembly434 which may be used to position the arms 232A, 232B from a low-profileaxial configuration to a radially-oriented deployed configuration, asshown in the figures. Once positioned for extension, one or moretelescoping members 236A, 236B may extend linearly at an angle relativeto one another (acute, right, or obtuse depending upon the desiredconfiguration) from each arm 232A, 232B. Alternatively, the telescopingmembers 236A, 236B may extend in a curved or arcuate manner to formcurved arm member when deployed. In yet another configuration, onetelescoping arm may extend linearly while the opposite arm extends toform a curved deployed arm. Having the arms telescope outwardly justbelow the leaflets may avoid entanglement with various ventricularobstructions such as the chordae tendineae CT and/or papillary musclesPM. With the arms fully extended, the proximal stabilizing structure 12may then be deployed for securement upon the upper leaflet surfaces, asshown in FIG. 14C.

Another variation of telescoping arm members may be seen in the end andside views of FIGS. 15A to 15C. These telescoping arm members may beused for either the first or second assembly, or both. The telescopingassembly 240 may generally comprise telescoping arms 242A, 242B whichmay be partially curved or straight and coupled to one another via apivoting assembly (not shown) to allow for an axially-elongated deliveryprofile. One or more telescoping members 244A, 244B may be slidablynested within each segment, as shown in FIG. 15C, so as to minimizeprofile and maintain rigidity in their fully deployed position. Themembers 244A, 244B may each have matching curvatures and have theirlongitudinal axis coincident with one another such that when the armsare deployed, they may extend to follow a perimeter of the mitral valve,as shown in FIG. 15B.

FIGS. 15D and 15E show yet another variation where two or more armmembers may be projected from within a catheter 54 to a deployedconfiguration where the arm members extend to form a curved or arcuateelement. The arm members may extend perpendicularly or at an anglerelative to the catheter 54 for extending over a valve, such as themitral valve, both supravalvularly and subvalvularly to compress uponthe annulus or upon the a periphery of the valve leaflets. Thus, thecatheter 54 may be inserted or directly positioned at the level of themedial or lateral mitral valve commissure with supravalvular andsubvalvular exit sites for the arm members to be placed in the, e.g.,subannular space, between the valve leaflets and the ventricle andseparate arm members to be placed in the, e.g., supraannular space, toachieve annular stabilization.

As illustrated in the perspective view of FIG. 15D, catheter 54 is shownhaving arm member deployment assembly 261 attached to a distal end ofthe catheter 54 via detachable coupling 253. The deployment assembly 261may define two or more openings 251 through which the arm members, whichare positioned within the catheter 54 during delivery, may be extendedthrough for deployment. The openings 251, in this variation, may bepositioned about the deployment assembly 261 to allow for the armmembers to extend in a curved or arcuate manner from the catheter 54.Thus, the openings 251 may be positioned in opposition to one another orat an angle relative to one another. An example is illustrated hereshowing at least two openings 251A and 251B positioned adjacent to oneanother about a circumference of assembly 261 for deploying at least twoarm members supravalvularly. Two additional openings 251C and 251D arealso shown adjacent to one another and distal to the openings 251A and251B, respectively, at a distance for deploying at least two arm memberssubvalvularly.

As shown in the perspective view of FIG. 15E, arm members 255A and 255Bare illustrated advanced from catheter 54 and extending throughrespective openings 251A and 251B. Also shown are arm members 257A and257B extending from respective openings 251C and 251D and projectingadjacent to respective arm members 255A and 255B. Each of the armmembers may extend from a straightened configuration within the catheter54 during delivery to a curved or arcuate configuration when urgeddistally from within the catheter 54, e.g., using a pushing mechanism orother actuator, and when released from the constraints of the catheter54 lumen. The arm members may curve into a shape which approximates aperiphery of the valve, such as the mitral valve, such that when urgedfrom the respective openings the opposing arm members extendperpendicularly or at an angle relative to the catheter 54 and curvetowards one another, as shown. For instance, as arm members 255A and255B project from their respective openings 251A and 251B, they mayextend at an angle relative to catheter 54 and also initially extendaway from one another to then curve and extend towards one another suchthat the deployed shape approximates the valve periphery. Arm members257A and 257B may similarly extend adjacent to arm members 255A and255B.

Each of the arm members may also form an atraumatic blunt end 259 so asto prevent or inhibit tissue damage as the arm members are projected.The arm members may be constructed from various biocompatible materialssufficient to provide flexibility yet are rigid or semi-rigid enough toprovide support to the valve leaflets, e.g., shape memory alloys such asnitinol, stainless steels, etc. Alternatively, the arm members may beconstructed so as to be form inflatable tubular structures that may haverigidity induced by an inflation gas, fluid, or other medium (e.g.,saline, water, etc.) introduced into the arm structures at asufficiently high pressure. Alternatively, the rigidity along the armmembers may be induced by inflating the arms with a hardening fluid.Additionally and/or alternatively, the arm members may have any numberof frictional components or projections (barbs, spikes, etc., or any ofthe projections or elements described herein) formed upon the contactsurfaces of the arm members to increase the fixation between the armsand the underlying tissue.

Moreover, the length of each arm member may be uniform with respect toone another or they may be varied depending upon the designedconfiguration and anatomy of the valve. While the arm members may beprojected to extend partially about the periphery of the valve, they mayalternatively be projected to extend distally such that the respectivedistal ends overlap upon one another at least partially to increaseannular rigidity.

Once deployed, the supravalvularly positioned arm members 255A, 255B maycompress against their respective subvalvularly positioned arm members257A, 257B such that the annular or leaflet tissue therebetween may becompressed and supported structurally. To further compress and supportthe tissue, the supravalvularly positioned arm members 255A, 255B andsubvalvularly positioned arm members 257A, 257B may be located alongseparate deployment devices. An example is illustrated in FIG. 15F,which shows catheter 54 having supravalvularly positioned arm members255A, 255B projecting from its distal end but with subvalvularlypositioned arm members 257A, 257B extending from a deployment assembly265 attached to a separate deployment catheter 263 which may bepositioned within catheter 54. The separation of the pair of arm membersmay allow for catheter 263 to be translated 267 relative to catheter 54to further compress or adjust the positioning of the assembly relativeto the valve.

FIGS. 16A and 16B illustrate top views of the interventional devicewhere placement of the middle hinge or pivot 254 may be varied. Forexample, as shown in FIG. 16A, hinge or pivot 25 may be located on theouter edge allowing the arm members to extend towards the periphery ofthe valve as much as possible. Alternatively, as shown in FIG. 16B, thehinge or pivot 254 may also be placed as close as possible to the centerof the mitral orifice so that the arm members may be positioned as closeas possible to the inner perimeter of the mitral valve MV to providesupport while distorting the leaflets as little as possible.

II. Deployment

FIGS. 17A to 17E illustrate one variation of the mechanism of deploymentfor an interventional device. A distal stabilizing structure 14 isadvanced beyond the distal opening 262 of the catheter sheath 54. Anactuation member 264 (e.g., wire, suture, catheter, etc.) may beattached to a distal stabilizing structure 14 may be tensioned oractuated while a proximal portion of the distal stabilizing structure 14is maintained against the catheter opening 104. With the proximalstabilizing structure 12 still constrained within the catheter 54, thearms of the distal stabilizing structure 14 may be reconfigured todeploy, as shown in FIGS. 17B-17C. For example, when an actuation forceis applied to the actuation member in a proximal direction, the distalend 261 of the distal stabilizing structure 14 is urged in a proximaldirection while the proximal end 263 of the distal stabilizing structure14 is prevented from proximal movement by the catheter sheath 54, thuspulling the distal end 261 towards the proximal end 263. With the distalstabilizing structure 14 fully in a laterally-elongated configuration,as shown in FIG. 17C, the catheter opening 262 may be withdrawn furtheruntil the proximal stabilizing structure 12 is exposed, as shown in FIG.17D. The actuation member 264 may then be tensioned further with thecatheter opening 104 used as a backstop against the proximal portion ofthe proximal stabilizing structure 12 to reconfigure the proximalstabilizing structure 12 into its laterally-elongated configuration, asshown in FIGS. 17D and 17E.

FIGS. 18A to 18F show perspective views illustrating how the one or moreinterventional devices 10, 10′ may be deployed relative to the mitralvalve leaflets for providing leaflet stabilization and/or anchoringdevices for a prosthetic valve. As shown, in a typical antegradeapproach (as discussed herein) a first interventional device 10 may beadvanced between the posterior and anterior mitral leaflets PML, AMLuntil the distal stabilizing structure 14 through the valve to asubannular position. The distal stabilizing structure 14 may be deployedfirst or both the proximal and distal stabilizing structures 12, 14 maybe reconfigured simultaneously such that proximal and distal stabilizingstructures 12, 14 reconfigure into their laterally-elongatedconfigurations on opposite sides of the annulus, compressing theleaflets, as shown in FIGS. 18A to 18C. The catheter 54 has been omittedfor clarity purposes only.

A second interventional device 10′ positioned within the catheter 54proximally of the first interventional device 10 may then be deployed ata second location along or upon the mitral valve by repositioning thecatheter accordingly and then advancing the distal stabilizing structure14′ to a subannular position and the proximal stabilizing structure 12′to a supra-annular position. Once suitably positioned, the stabilizingstructures 12′, 14′ may be deployed sequentially or simultaneously tolock upon their respective leaflet surfaces, as shown in FIGS. 18D to18F.

Deployment of the interventional device(s) may be biased along theanterior side of the mitral valve, as shown in FIG. 18F. The mitralvalve is bound by muscular tissue MW on the posterior side of the valveonly. The inner wall of the mitral valve, surrounding the anteriorleaflet, is bound by a thin vessel wall TVW separating the mitral valveannulus from the inferior portion of the aortic tract (as shown in FIG.20A). As a result, little native structural support, if any at all, isprovided on the anterior side of the mitral annulus. Therefore, bydeploying each interventional device 10, 10′ such that the majority ofthe stabilizing assemblies lie on or along the anterior leaflet, theinterventional device(s) 10, 10′ provide additional support forstabilizing the annulus and/or anchoring a replacement valve, as shownin FIG. 20B. In order to provide adequate circumferential support for acatheter-delivered prosthetic valve, the interventional devices 10, 10′together preferably cover, e.g., at least about 60% of the circumferenceof the mitral valve.

The first and second interventional devices 40, 10′ may be accordinglypositioned in the anterior and posterior commissures such that thecurved arm members follow along a periphery of the valve annulus.Moreover, although two interventional devices 10, 10′ are shown, asingle interventional device may be used alone at either commissure. Thearms may also be configured at various angles depending upon the desiredconfiguration. Likewise, more than two interventional devices may alsobe deployed.

FIG. 19A illustrates a top view of a dysfunctional mitral valve MV wherethe posterior and anterior mitral leaflets PML, AML fail to coapt whileFIG. 19B illustrates a top view of the mitral valve MV having a firstand second interventional device 10, 10′ deployed and positioned ateither commissure. As shown, the interventional devices 10, 10′ mayfollow the periphery of the annulus while maintaining a central regionof the mitral valve MV uninhibited such that the leaflets may besupported by the assemblies to facilitate coaptation of the leaflets.

III. Locking Mechanisms

Once the interventional device 10 has been deployed, the device 10 maybe locked into its deployed shape and left implanted upon or along themitral valve. To ensure that the device remains secured upon the valveleaflets, various locking mechanisms may be implemented into the device.

In the variation shown in the front and perspective views of FIGS. 21Ato 21C, the extension arm members may generally comprise an attachmentmember 270 which is attached or connected, for instance, along the armmember 272. The attachment member 270 may further extend linearly orcurvilinearly along an extending member 274 which has a first atraumaticsurface which may contact against a surface of the leaflet. When theinterventional device has been reconfigured into its laterally-elongatedconfiguration, as shown in FIG. 21C, the attachment member 270 mayextend along a circumferential arm from the arm member at a distancefrom the proximal and distal stabilizing structures 82, 84. The oppositesurface of extending member 274 may define one or more projections orteeth 276 for coming into a ratcheted locking engagement with an opposedcorresponding set of projections on a second extending member of anadditional repair assembly. In the example shown, the projections orteeth 276 may be positioned along the extending member 274 such that theatraumatic side of the member 274 may rest upon the surface of the valveleaflet while the projections or teeth 276 may extend away from theleaflet surface.

FIGS. 22A to 22F illustrate an example of how one or more interventionaldevices 80, 80′ may be deployed relative to one another such that theextending members 274, 274′ may be brought into an engaging contact. Aspreviously described, the first interventional device 80 may be deployedand expanded at a first commissure such that the extending member 274 isdeployed along a periphery of the valve annulus with the projections orteeth 354 positioned away from the leaflet surface, as shown in FIGS.22A to 22C. The second repair assembly 80′ may then be deployed andexpanded at the second commissure in apposition to the first assembly 80such that the second extending member 274′ is also deployed along theperiphery of the valve annulus. The second assembly 80′ may have theprojections or teeth 276′ positioned towards the leaflet surfaces suchthat they may come into an engaging contact with the first extendingmember 274, as shown in FIGS. 22D to 22F. The engagement between theextending members 274, 274′ may be ratcheted or loosened to adjust thepositioning of the assemblies 80, 80′ and the amount of support impartedto the underlying leaflets.

FIGS. 23A to 23B illustrate front and perspective views of yet anotherlocking mechanism variation for a interventional device where a pair ofcurved stabilizing arms 280A, 280B may be combined with a distalstabilizing structure 84. The curved arms 280A, 280B may be folded whendelivered through the catheter 54, as shown in FIG. 23A, but may extendradially outward to curve towards one another at their respective distalends such that the curved arms 280A, 280B extend over or upon theleaflets and coincide between the leaflet commissure. The distal ends ofthe each curved arm 280A, 280B may define one or more openings 284through which a locking suture or wire 282 may be passed to secure thearms to one another. In this manner, the positioning of the arms overthe span of the valve may further provide stabilization over the entirevalve.

FIG. 23C illustrates a top view of another locking mechanism variationfor securing two or more interventional devices. A pair of curvedstabilizing arms 280A, 280B may be combined with a distal stabilizingstructure 84 to secure one interventional device to a secondinterventional device. The curved arms 280A, 280B may be folded whendelivered through the catheter 54, as shown in FIG. 23A, but may extendradially outward so as to conform to the shape of the arms of thestabilizing structures and/or native valve. The length of thestabilizing arms 280A, 280B may be adjusted so as to exceed that of thedistal arms, thereby extending past the ends of the distal arms of oneinterventional device to overlap with and/or connect to the distal armsof a second interventional device. Stabilizing arms 280A, 280B may beheld in place through, e.g., pins, hooks, tabs, wires, sutures, etc.anywhere along the arms of the second interventional device.

FIGS. 24A to 24C illustrate perspective and partial cross-sectional sideviews of yet another variation which utilizes the devices illustratedabove in FIGS. 15D and 15E. A portion of the surrounding mitral wall MWmay be seen in the figure for reference. After advancing the steerablecatheter intravascularly to, e.g., the mitral valve located within theleft atrial chamber, at the medial or lateral commissure from the atrialside or ventricular side, the catheter 54 may be positioned such thatthe detachable coupling 253 is positioned at least partially through thevalve. With the proximal openings 251A and 251B positioned above thevalve within the left atrium and the distal openings 251C and 251Dpositioned below the valve within the left ventricle, the supravalvulararm members 255A and 255B may be advanced from within the catheter 54into their deployed configuration situated, e.g., in the supra-annularspace upon the annulus AN or upon the superior surfaces of the posteriorPML and anterior mitral leaflets AML, and subvalvular arm members 257Aand 257B may be similarly advanced from within the catheter 54 intotheir deployed configuration, e.g., in the sub-annular space upon theannulus AN or upon the inferior surfaces of the posterior PML andanterior mitral leaflets AML, in apposition to their respectivesupravalvular arm members. As described above, the arm members may beuniform in length relative to one another or non-uniform in length andeither partially or completely circumferentially deployed over or uponthe valve.

FIG. 24B illustrates the partial cross-sectional side view of thecatheter 54 positioned trans-septally in a superior position relative tothe mitral valve. The deployed arm members may be seen after deploymentand upon the annulus AN or valve leaflets. Because of the low-profile ofthe arm members, particularly the subvalvularly positioned-arm members257A and 257B, they may be introduced into the subannular space withinthe left ventricle LV and through the surrounding chordae tendineae CTattached to the leaflets without being inhibited.

After assuring adequate arm member placement, the coupling 253 of thecatheter 54 may then be disconnected from the shaft of the catheter 54leaving the deployed arm members in position. Because the arm membersmay have a spring like quality while imparting compressive and/or radialforces to the underlying valve, they may function to stabilize theassembly at the annular level.

The assembly may further provide a platform for placement of animplantable valve prosthesis which may be secured to the valve withoutthe need for sutures, as illustrated in the partial cross-sectional sideview of FIG. 24C. In patients with mitral regurgitation who arecandidates for valve replacement, the assembly may be placed, asdescribed herein, while under fluoroscopic, echocardiographic, and otherimaging guidance. The rigidity of the arm member assembly may provide aplatform for placement of a transcatheter valve and/or suturelessprosthesis such that a replacement valve prosthesis 398 may be advancedintravascularly and deployed through the valve while anchoring againstor along the reinforced valve annulus and/or leaflets or directlyagainst the deployed arm members.

Another approach is placement of assembly under direct vision orsurgically. The valve commissure is identified and the tip of thecatheter 54 placed at the junction of the subannular and supraannularregions. The assembly may also be percutaneously, trans-atrially,trans-septally, trans-apically or directly introduced and implanted aswell. Passage of the arm members is continued into the subannular spacefollowed by passage of the arm members into the supraannular space. Thedescribed approaches and the present device also may be used to providea stable, rigid or semi-rigid annulus for the deployment oftranscatheter valve and sutureless prostheses in other locations, suchas the tricuspid valve.

In yet another variation, the catheter 54 may be utilized with anadditional catheter 54′, which may also be advanced into the heartchamber adjacent to the first catheter 54 or through an alternativepath, to increase annular rigidity. Regardless of the entry path, withthe first catheter 54 positioned at a first location about the valve,such as at a first location of the valve commissure, the second catheter54′ may be positioned simultaneously or sequentially at a secondlocation about the valve, such as at a second location of the oppositevalve commissure, as shown in the perspective view of FIG. 24D.

With the arm members 255A and 255B deployed supravalvularly and armmembers 257A and 257B deployed subvalvularly, the additionalsupravalvular arm members 255A′ and 255B′ may be deployedsupravalvularly and additional arm members 257A′ and 257B′ may bedeployed subvalvularly. The additional arm members of the secondcatheter 54′ may be deployed sequentially or simultaneously with thedeployment of the arm members of the first catheter 54. Once each of thearm members have been deployed, each respective connector may bedetached to leave the arm member assembly implanted upon the valve andthe respective catheters 54, 54′ may be withdrawn. As previouslydescribed, the arm members may then be left implanted to providestructural support to the valve or a valve prosthesis may be introducedand implanted through the valve utilizing the arm members for structuralsupport.

Another variation on a locking mechanism for the interventional deviceis illustrated in the side views of FIGS. 25 to 27 which show an outercatheter 290 which may be temporarily coupled to the proximal link 298of the interventional device 10 via an outer catheter attachment 294,e.g., screw thread; gripping element with a release wire, or othersuitable attachment mechanism. A separate inner catheter or wire 292 maypass through the outer catheter 290 and within a lumen 296 definedthrough the device 10 to a distally positioned inner catheter attachment298, e.g., screw thread, gripping element with a release wire, or othersuitable attachment mechanism. The inner catheter or wire 292 may beoptionally pre-shaped or configured to hold or maintain a predeterminedshape for holding the assembly 10 in the desired shape or configurationfor facilitating deployment. Of course, the inner catheter or wire 292may also be maintained in a straightened and flexible configurationwhich may allow the assembly 10 to naturally form itself into anappropriate curve.

During delivery and prior to assembly expansion, the inner catheter orwire 292 may be maintained in a stable position relative to the outercatheter 290. The inner catheter or wire 292 may be actuated ortensioned relative to the outer catheter 290 to expand or extend thedevice into its deployed configuration. To secure thelaterally-elongated configuration, one variation for locking the devicemay comprise an outer catheter attachment screw 308 positioned at adistal end of the outer catheter 290. The attachment screw 308 maydefine a threaded portion 310 which may be rotated to engage thethreading 306 defined along the lumen 306 of the device 10 such that thescrew 308 is advanced distally through the lumen 306 until a lockingcollar 312 secures the proximal end of the device 10 relative to thedistal end of the device 10, as shown in FIG. 27.

To release the device 10 from the catheters, one or more pairs ofengagement arms having one or more protrusions 300 may comprise theinner catheter attachment 298 at the distal end of the inner catheter290. The protrusions 300 may be maintained against one or morecorresponding locking members 302 defined along the distal end of thelumen 296. A release wire positioned through a lumen 304 defined throughthe inner catheter 292 may be tensioned to allow the engagement arms torelease from the locking members 302 thus allowing the interventionaldevice 10 to detach from the catheter, as shown in FIG. 26.

In yet another variation of the interventional device(s), FIG. 28illustrates a side view of another variation where the device mayincorporate one or more respective locking mechanisms 320 (e.g., pins,ratchets, etc.) positioned along a upper or lower surface of the armmembers such that the locking mechanisms 320 are received intorespective receiving channels 322 or another cooperating structuredefined along apposed arm members when reconfigured into the deployedconfiguration. As previously described, a tensioning wire, suture, orcatheter 324 may be coupled to a distal annular structure 14 such thatwhen tensioned, the device may collapse into its laterally-elongatedconfiguration. Also, as the arm members fold into theirlaterally-elongated configuration, the locking mechanisms 320 may beconfigured to penetrate through the leaflets and to be received intotheir respective receiving channels 322 and locked automatically tosecure the arm members into their deployed configurations.

Examples of the different types of locking mechanisms 320 which may beutilized with the stabilizing assemblies may be seen the cross-sectionalside views of FIGS. 29A and 29B. In this example, ratchet 330 may have atapered lock 332 which may be incorporated into a distal arm member ofthe interventional device. Tapered lock 332 has a proximal shoulder 331of larger diameter than openings 334. As the attached tensioning wire336 is pulled, the tapered locking portion 262 may be pulled through theone or more openings 334 defined along the interventional device, e.g.,through the pivoting mechanism, until the tapered locking portion 332 isfully drawn through the assembly to lock the device in its deployedconfiguration, as in FIG. 29B. FIG. 30 illustrates a cross-sectionalside view of another variation of a locking ratchet 338 but in place ofshoulder 331 the tapered portion may define one or more serrations orprojections 340 to engage complementary features within openings 334 toenhance the locking securement.

FIGS. 30A and 30B illustrate cross-sectional side views of anotherlocking mechanism which may be drawn through the interventional deviceto lock the device in its deployed configuration. In this variation, thedistal end of the interventional device may have a locking member 342such as a wire or suture which may be tensioned through theinterventional device and crimped or flattened to form a broadenedretainer 344 directly upon the member 342 to prevent its withdrawalthrough the assembly.

FIGS. 31A and 31B illustrate cross-sectional side views of yet anotherlocking mechanism. In this example, the locking member 342 may betensioned through the interventional device and a crimping collar 346may be positionable over the member 342 and crimped upon the member 342when compressed member 342 is drawn tightly.

FIGS. 32A to 32C illustrate cross-sectional side views of anotherlocking mechanism where the locking member 342 may be tensioned to holdthe interventional device into its laterally-elongated configuration.One of the proximally positioned arm members or the proximal engagementlink 32 may incorporate a locking pin 348 which is urged against thelocking member 342 via a biasing element 350 such as a spring. As thelocking member 342 is drawn proximally through the interventionaldevice, the biased pin 348 may be inserted at least partially, as shownin FIG. 32B, or entirely, as shown in FIG. 32C, through an opening orslot 352 defined through a distal portion of the member 342. With thelocking pin 348 inserted through the opening or slot 352, furthermovement of the member 342 may be inhibited relative to theinterventional device thereby locking the configuration of the assembly.

FIG. 33A illustrates a cross-sectional side view of yet anothervariation of a locking mechanism where a wire or rod 354 may betensioned to move the proximal and distal stabilizing structures 12, 14into their expanded configuration. A separate collet 356 may slide alongthe wire or rod 354 when the collet 356 is in an open configuration suchthat one or more movable locking members 358 extending radially withinthe collet 356 provide enough space for the wire or rod 354 to travelfreely through, as shown in FIG. 33B. Once the interventional device hasbeen desirably expanded, the collet 356 may be drawn down distally alongthe wire or rod 354 and locking members 358 moved radially inward toclamp down upon the wire or rod 354, as shown in FIG. 33C, therebypreventing movement of the collet 356 relative to the wire 354 and thuspreventing or inhibiting the interventional device from reconfiguringback into its low-profile shape.

FIG. 34 illustrates a cross-sectional side view of yet another lockingmechanism where a fastener 362 having threading 364 along its length maybe simply rotated or screwed into the expanded interventional device tolock the configuration of the proximal and distal stabilizing structures12, 14.

FIGS. 35A and 35B illustrate cross-sectional side views of anotherlocking mechanism where a rivet 370 having a deformable collar 368 maybe secured upon the interventional device once the assembly hasreconfigured into its deployed configuration. A separate press 366 maybe brought to bear upon the deformable collar 368 such that the collar369 deforms radially to lock a position of the rivet 370 relative to thearm members. In this manner, the expanded configuration of the proximaland distal stabilizing structures 12, 14 may be secured.

Yet another locking mechanism is illustrated in the front and detailfront views of FIGS. 36A and 36B which show the relative positioning ofthe proximal and distal engagement links 32, 40 along the stabilizingstructures 12, 14. In this variation, a tensioning suture or wire 372may pass through the interventional device and couple the distal andproximal engagement links 32, 40 to one another. With the suture or wire372 secured to at least one of the links, the remaining end of thesuture or wire 372 may be adjustably secured to the opposing link usinga one-way sliding knot to allow for adjustable locking of theinterventional device. The remaining end of the suture or wire 372 may,for example, pass through a central opening 332 of the proximalengagement link 52 and then pass proximally through a first laterallyoffset proximal opening 376 and then crossover the wire 372 to secondlaterally offset proximal opening 374, from which it extends to thedistal engagement link 32. Pulling the suture or wire 372 in a firstdirection 380, e.g., towards the opposing link, may allow for tensioningadjustment of the proximal and distal stabilizing structures 12, 14while sliding of the suture or wire 372 in the opposing direction 382 isprevented due to friction between the portions 377 of the suture or wirethat engage each other, thus locking the upper and lower arm members.This configuration may also allow adjustments to be made to thestructures to allow for the release of the device from a particularconfiguration and the re-locking of the device, if so desired. Forexample, by releasing tension in the crossover portion 377 of the sutureor wire 372, it will be allowed to slide in direction 382 to release thedistal annular structure.

Yet another variation is shown in the top view of FIG. 37 whichillustrates a variation where a coupling mechanism such as a slidingsuture lock 384 may be advanced over wires or sutures 386 extending fromthe arms of multiple assemblies to create a rigid or secure connectionbetween each of the implanted assemblies 12, 12′ in theirlaterally-elongated configurations upon the valve leaflets. This isparticularly useful when the distal and proximal stabilizing structuresare deployed so that their combined periphery is biased towards one endof the valve, as shown, for example, in FIG. 18F.

IV. Valve

In any of the interventional device variations described, one or moreassemblies may be utilized alone or in combination with an implantedstent, scaffold, or valve implant. In the variation shown in theperspective view of FIGS. 38A and 38B, an example is illustrated showinghow a sell-expanding valve implant or scaffold 398 may be deployedrelative to the interventional devices. Once the one or moreinterventional devices 80, 80′ have been deployed and expanded along themitral valve, catheter 54 may be repositioned above the mitral valvewith one or more wires or sutures 392 extending from the catheter 54 andto the one or more links 52, 52′. A pusher catheter or shaft 390 havingvalve implant or scaffold 392 attached may be urged from the catheter 54to push the implant or scaffold 398 in its fully expanded shape viaopenings or loops 394 located along the implant or scaffold 392 throughwhich may be looped around the wires or sutures 392 extend to help guidethe implant 398 into position in engagement with the assemblies 80, 80′.The implant 398 may have its lumen 396 positioned to coincide with thevalve opening such that the implant 398 is secured above, below, orthrough the valve. Each of the links may comprise one or moreretractable locks 394 which may allow the openings or loops 394 to slideover and force the retraction of the locks 402, as shown in FIG. 39,until the openings or loops 394 have cleared the locks 402 after whichthey may extend outwardly to lock a position of the valve 398 relativeto the interventional devices 80, 80′.

To help secure the implant 398 relative to the valve, the one or moreassemblies 80, 80′ may incorporate one or more protrusions 400, aspreviously described, along the arm members facing the valve centralregion, as shown in the perspective view of FIGS. 40A and 40B. Theprotrusions 400 may extend inwardly from the arm members and engage thesides of the implant 400 or interstices therein to resist or inhibit anymovement between the implant 398 relative to the valve, as shown in FIG.40A. In this example, implant 398 will be held within catheter 54 untilpositioned within the interventional devices 80 then released so as toexpand into engagement with the inner walls thereof.

Yet another variation for securing the interventional devices 80, 80′relative to one another as well as to provide an engagement surface forany potential implant is shown in the perspective view of FIG. 41A. Withthe one or more interventional devices 80, 80′ deployed along the valve,a supporting ring 404 having a circumferential structure with one ormore openings 406 defined along the circumference may be deployed fromthe catheter 54 and guided via wires or sutures 392 extending throughthe openings 406. The terminal ends of the wires or sutures 378 may beattached to the respective links 52, 52′ such that the openings 406 mayslide directly upon and over the links 52, 52′. Each of the links maycomprise one or more retractable locks 402 which may allow the openings406 to slide over and force the retraction of the locks 402, as shown inFIG. 39, until the openings 406 have cleared the locks 402 after whichthey may extend outwardly to lock a position of the ring 404 relative tothe stabilizing structures 80, 80′.

While the support ring 404 may be comprised as a simple ring defining anopening 408 therethrough, as shown in the top view of FIG. 41C, the ringmay be configured into alternative variations. One example is shown inthe top view of FIG. 41B where supporting ring 403 may comprise apartial ring, such as a C-clip, in which the terminal ends of the clipare coupled to one another via a connecting wire or elastic band 405such that an opening 407 is defined by the structure. The partial ringmay also be comprised of individual segments 401 which are hinged orlinked to one another such that the supporting ring 403 may conform tovariations in the alignment of the interventional devices 80, 80′ or tovariations in the anatomy as well while still providing structuralsupport. Another variation is shown in the perspective view of FIG. 41Dwhich illustrates a support ring 404 having a collar 410 which extendsaxially away from the ring 404 and defines while defining an opening 412therethrough. Collar 410 may have a more circular shape, greater heightand smaller diameter than ring 404 so as to provide a cylindrizedplatform in which a stented valve may be deployed.

FIGS. 42A to 42B illustrate perspective views of additional ringedstructures which may be attached to the one or more interventionaldevices 80, 80′. In one variation, supra-annular ring 420, shown in FIG.42A, may comprise a number of projections or protrusions 422 or loop orclip element 424, as shown in FIG. 42B, which extend outwardly from thering circumference.

In yet another variation of the interventional device, a supporting ringmay be utilized in combination with one or more retaining members ratherthan with an interventional device. FIG. 43A shows a cross-sectionalside view of an example of how a ring 452 may be axially-elongated andpositioned within a catheter 54 along with proximally and distallypositioned retainer members 450, 450B for intravascular delivery. FIG.43B shows a perspective view of the deployed ring assembly wheresubannular retainer members 450A, 450B may be configurable from a lowprofile shape during delivery to a deployed shape in which the distalarms of the retainer members extend into curved, arcuate, orsemi-circular configurations for contact the sub-valvular surface of theleaflets. Accordingly, the retainer members 450A, 450B may be made fromresilient materials such as shape memory materials (e.g.,nickel-titanium alloys, shape memory polymers, etc.) Locking couplings458A, 458B may be positioned to extend proximally of each respectiveretainer member 450A, 450B.

The prosthetic supra-annular ring 452 may be shaped or sized similarlyto a periphery of the mitral valve and/or be configured to support animplanted prosthetic valve. One or more openings 454A, 454B may also bedefined at either end of the ring along the circumference to provideguidance for wire or sutures 456A, 456B which may pass through eachrespective opening. The couplings 458A, 458B may be attached torespective wire or suture 456A. 456B such that the couplings may bereceived within the respective openings 454A, 454B defined through thering 452 in a locking manner when each wire or suture is tensioned tosecure a position of each respective retainer member 450A, 450B relativeto the ring 452. The couplings 458A, 458B may define one or more taperedmembers which allow for their insertion into and/or through the openings454A, 454B and engagement with a flange 457 therein to inhibit theirretraction or withdrawal to allow for adjustable securement of the ring452 to retainer members 450A, 450B upon the mitral valve annulus, asshown in FIG. 43C. Alternatively, various other mechanisms such asratcheting teeth, pawls, spherical locking elements, hitch/ringassembly, etc. may be used to couple retainer members 450A, 450B to ring452.

An example of how the ring assembly may be deployed is shown in thepartial cross-sectional side views of FIGS. 44A to 44F. The mitral valveleaflets are not shown only for clarity. As illustrated in FIGS. 44A and44B, the distal end of catheter 54 may be placed through a firstcommissure of the mitral valve MV from the left atrium LA into the leftventricle LV and a first retainer member 450A and coupling 458A may bedeployed from the catheter in the subannular space below the leaflets toreconfigure into a deployed configuration. The catheter 54 may bewithdrawn proximally into the left atrium LA and the ring 452 may thenbe ejected from the catheter 54 from within the left atrium LA superiorto the mitral valve MV as well as with the tether 456A remainingattached to the first retainer member 450A through the opening in thering 452. With the catheter 54 used as a backstop against the ring 452,the tether 456A may be tensioned and pulled to draw the coupling 458Ainto the ring opening to lock the retainer member 450A against the valveannulus AN and/or leaflets as shown in FIGS. 44C and 44D. The catheter54 distal end may then be placed through the ring 452 in the oppositecommissure to deploy the second retainer member 450B inferior to themitral valve annulus AN and within the left ventricle LV, as shown inFIG. 44E. The tether 456B may then be tensioned to draw the secondretainer member 450B against the valve annulus AN and to lock thecoupling 458B to the ring to secure the ring 452 position relative tothe valve, as shown FIG. 44F.

In yet another variation, FIGS. 45A to 45C show another variationillustrating how a ring 452 may be deployed in combination with a distalstabilizing structure 84. As shown in the cross-sectional side view ofFIG. 45A, the ring 452 may be axially-elongated into a low-profileconfiguration for delivery positioned between a distal stabilizingstructure 84 and an optional proximal stabilizing structure 84′. Thedistal stabilizing structure 84 may be deployed from the catheter 54 andsecured, as shown in FIG. 45B, in a subannular position. The ring 452may then be deployed in a supra-annular position and allowed toreconfigure into its deployment shape. With tethers 456A, 456B passingfrom catheter 54 and through respective openings along the ring 452, apusher catheter 460 may be deployed to push or urge a respective lockingretainer 462A, 462B along a respective tether 456A, 456B to secure theposition of the first and second stabilizing assemblies 84, 84′ relativeto the ring 452, as shown in FIGS. 45C and 45D, such that the valveleaflets are secured therebetween. FIG. 45E shows a cross-sectional sideview of an example of a locking retainer 462A having a lumen 464 forsliding along tether 456A (uni-directionally in one example) a pair ofangled pawls which engage tether 456A and a tapered portion for lockinginto the opening defined along the ring 452.

In any of the variations of the interventional devices described herein,various features or projections such as pins 180, castellations 182,raised tabs 184, or any other projections, protrusions, bumps, orfeatures which may facilitate engagement with a replacement mitral valveimplant may be formed along one or more arm members, as shown in theperspective views of FIGS. 46A and 46B. These features may be locatedalong the surface of the arm members which face the central region ofthe mitral valve when deployed or on any other surface of the armmembers as may be useful for enhancing engagement with the prostheticvalve.

It should be noted that any of the ring members described above inconnection with, e.g. FIGS. 38-46, may be configured to receive aseparate catheter-delivered valve for deployment therein, or may haveeither a temporary or permanent valve pre-mounted therein. Since arelatively long period of time may elapse between placement of theanchor and implantation of the prosthetic valve, a temporary valve sewninto or otherwise secured within the anchoring structures of theinvention assures proper regulation of blood flow in the interim. As thename denotes, temporary valves are not intended for long term use,typically being required for a period from about 15 minutes to severalhours or at most a few days. Prosthetic valves may be implanted within atemporary valve or may be implanted after the temporary valve has beenremoved.

V. Intravascular Approaches to the Mitral Valve

In one example for delivering and deploying one or more interventionaldevices 10, FIGS. 47A to 47K illustrate partial cross-sectional sideviews of a heart H interior to show a typical antegrade approach. Asshown in FIG. 47A, a guidewire 9 may be advanced intravascularly usingany number of techniques, e.g., through the inferior vena cava IVC orsuperior vena cava SVC (not shown), through the atrial septum AS andinto the right atrium RA. Catheter 54 may be advanced along theguidewire 9 and into the right atrium RA until reaching the anteriorside of the atrial septum AS, as shown in FIG. 47B. Once the catheter 54reaches the anterior side of the atrial septum IAS, a piercing needleand/or dilator 500 may be advanced through the catheter to cross theatrial septum AS from the right atrium RA into the left atrium LA, asshown in FIG. 47C. At this point, the guidewire 9 may be exchanged forthe needle 70 and the catheter sheath withdrawn. A catheter 54 may thenbe advanced over the guidewire 9 and into the left atrium LA and into aposition above the dysfunctional mitral valve MV, as shown in FIG. 3D.

In a typical antegrade approach, the distal opening 262 of the catheter54 may be advanced into proximity to the mitral valve MV and optionallypassed between the posterior mitral leaflet PML and anterior mitralleaflet AML and at least partially past the plane of the mitral valveannulus, as shown in FIG. 47E. A first interventional device 10 isadvanced through the catheter 54 to the distal end of the catheter 54.The distal stabilizing structure 14, in its axially-elongatedconfiguration, may then be advanced distally from the catheter 54 andbelow the valve leaflets and then deployed such that the assembly isreconfigured to its laterally-elongated configuration withoutinterference from the chordae tendineae CT or papillary muscles PMwithin the left ventricle LV, as shown in FIGS. 47F and 47G.

With the distal stabilizing structure 14 deployed in a subannularposition, the distal end of catheter 54 may be partially withdrawnfurther into the left atrium LA and the proximal stabilizing structure12 may then be deployed from the catheter 54 and reconfigured into itslaterally-elongated shape in a supra-annular position, as shown in FIGS.47H and 47I, such that portions of the posterior and anterior mitralleaflets PML, AML are secured between the arms of the stabilizingstructures 12, 14. An actuation member 504 (e.g., wire, suture,catheter, etc.) may be coupled to the interventional device 10 and usedto reconfigure and/or lock the proximal and distal stabilizingstructures 12, 14 into their laterally-elongated configurations, aspreviously described herein.

The process may be repeated to position and deploy a secondinterventional device 10′ at a second end of the mitral valve MV suchthat the leaflets are secured between the arm members of each of thestabilizing assemblies 12, 14 and 12′, 14′. With the deployed armmembers compressing the leaflets therebetween, the curved or arcuateshape of the deployed assemblies may follow along a periphery or annulusof the mitral valve MV such that a central region of the valve remainsuninhibited and the posterior and anterior mitral leaflets PML, AML maycoapt sufficiently. The interventional device may further eliminate orreduce prolapse of the leaflets into the left atrium by effectivelyshortening their length and moving their hinge points inwardly from theheart wall.

While the one or more interventional devices 10, 10′ may be utilizedalone, a stent, scaffold, or replacement valve assembly 506 mayoptionally used as well in combination with the one or more assemblies.FIGS. 47J and 47K show one example where replacement valve assembly 506may be further delivered through the catheter 54 via delivery wire orcatheter 508 and positioned within the central region defined betweenthe stabilizing structures 12, 14 and 12′, 14′. The valve assembly 506may then be expanded into engagement with the stabilizing structuressuch that the valve assembly 506 extends above, below, or entirelythrough the mitral valve MV. Examples of preassembled, percutaneousprosthetic valves include, e.g., the CoreValve Revalving™ System fromMedtronic/CoreValve Inc. (Irvine, Calif., USA), Edwards-Sapien fromEdwards Lifesciences (Irvine, Calif., USA).

FIGS. 48A to 48I illustrate another variation for delivering anddeploying one or more interventional devices using a typical retrogradeapproach. In this example, a guidewire 9 may be advanced intravascularlyvia a femoral approach through the aorta AO and aortic valve AV and intothe left ventricle LV of the heart H, as shown in FIG. 48A. The catheter54 may be advanced along the guidewire 9 until the catheter distal endis positioned within the left ventricle LV in proximity to the mitralvalve MV, as shown in FIGS. 48B and 48C. The distal end of the catheter54 may be optionally advanced at least partially through the mitralvalve MV and into the left atrium LA where the distal stabilizingstructure 14 may be deployed from the catheter 54, as shown in FIG. 48D,and reconfigured into its expanded configuration for contact against thesupra-annular surfaces of the posterior and anterior mitral leafletsPML, AML, as shown in FIG. 48E. With the distal stabilizing structure 14deployed, the catheter 54 may be retracted at least partially back intothe left ventricle LV where the proximal stabilizing structure 12 may bedeployed from the catheter and then reconfigured into its deployedconfiguration, as shown in FIGS. 48F and 48G.

A second interventional device 10′ may be deployed. A second pair ofproximal and distal structures 12′, 14′ may be deployed from thecatheter 54 and positioned along the mitral valve MV in an apposedposition relative to the first assemblies 12, 14 using the samesubannular approach, as shown in FIG. 4H. As previously described, astent, scaffold, or replacement valve assembly 506 may be optionallydelivered through the catheter 54 and positioned through the centralregion defined between the stabilizing assemblies 12, 14 and 12′, 14′and deployed therein such that the valve assembly 506 extends above,below, or through the mitral valve MV, as shown in FIG. 48I. Examples ofpreassembled, percutaneous prosthetic valves include, e.g., theCoreValve Revalving™ System from Medtronic/CoreValve Inc. (Irvine,Calif., USA), Edwards-Sapien.

In any of the variations and examples described herein, differentfeatures may be combined between the embodiments described in variouscombinations depending upon the desired device and results.

The applications of the disclosed invention discussed above are notlimited to certain treatments or regions of the body, but may includeany number of other treatments and areas of the body. Modification ofthe above-described methods and devices for carrying out the invention,and variations of aspects of the invention that are obvious to those ofskill in the arts are intended to be within the scope of thisdisclosure. Moreover, various combinations of aspects between examplesare also contemplated and are considered to be within the scope of thisdisclosure as well.

We claim:
 1. A heart valve device comprising: a first assembly having afirst pair of first arm members pivotally coupled to a second pair ofsecond arm members at a first link and a second link, wherein the firstarm members are coupled together at a first joint and the second armmembers are coupled together at a second joint, the first assemblyhaving a low-profile delivery configuration and an expanded deployedconfiguration such that the first and second links are spaced laterallyapart from each other by lengths of the first and second arm members;and a second assembly having a third pair of third arm members pivotallycoupled to a fourth pair of fourth arm members at a third link and afourth link, wherein the third arm members are coupled together at athird joint and the fourth arm members are coupled together at a fourthjoint, the second assembly having a low-profile delivery configurationand an expanded deployed configuration such that the third and fourthlinks are spaced laterally apart from each other by lengths of the thirdand fourth arm members, wherein the first and second assemblies in thedeployed configuration are configured to clamp native valve leafletsand/or a native annulus therebetween, wherein, in the expanded deployedconfiguration, the first arm members and second arm members togetherdefine an interior arcuate surface configured to face away from a heartwall and an exterior arcuate surface configured to face towards theheart wall such that the first assembly defines an arcuate elementconfigured to approximate a periphery of a portion of the nativeannulus.
 2. The device of claim 1 wherein the low-profile configurationof the first assembly is an axially-elongated configuration.
 3. Thedevice of claim 1 wherein the first assembly in the low-profileconfiguration is configured for placement within a delivery catheterlumen.
 4. The device of claim 1 wherein the low-profile configuration ofthe second assembly is an axially-elongated configuration.
 5. The deviceof claim 1 wherein the second assembly in the low-profile configurationis configured for placement within a delivery catheter lumen.
 6. Thedevice of claim 1 wherein reconfiguring the first assembly from thedelivery configuration to the deployed configuration comprises urging adistal end of the first assembly proximally towards a proximal end ofthe first assembly.
 7. The device of claim 1 wherein reconfiguring thesecond assembly from the delivery configuration to the deployedconfiguration comprises urging a distal end of the second assemblyproximally towards a proximal end of the second assembly.
 8. The deviceof claim 1 wherein the expanded deployed configuration of the firstassembly is a laterally-elongated configuration.
 9. The device of claim1 wherein the expanded deployed configuration of the first assembly isan expanded curved configuration.
 10. The device of claim 1 wherein theexpanded deployed configuration of the second assembly is alaterally-elongated configuration.
 11. The device of claim 1 wherein theexpanded deployed configuration of the second assembly is an expandedcurved configuration.
 12. The device of claim 1 further comprising alocking mechanism for securing the first assembly in the deployedconfiguration.
 13. The device of claim 1 further comprising a lockingmechanism for securing the second assembly in the deployedconfiguration.
 14. The device of claim 1 wherein the first assemblycomprises a tissue engaging surface.
 15. The device of claim 1 whereinthe second assembly comprises a tissue engaging surface.
 16. The deviceof claim 1 further comprising a stent assembly anchorable to the firstand/or second assembly.
 17. The device of claim 1 further comprising avalve assembly anchorable to the first and/or second assembly.
 18. Thedevice of claim 1, wherein, in the expanded deployed configuration, afirst distance between the first link and the second link is greaterthan a second distance between the third link and the fourth link.
 19. Aheart valve device comprising: a first assembly having a first pair offirst arm members pivotally coupled to a second pair of second armmembers at a first link and a second link, wherein the first arm membersare coupled together at a first joint and the second arm members arecoupled together at a second joint, the first assembly having alow-profile delivery configuration and an expanded deployedconfiguration such that the first and second links are spaced laterallyapart from each other by lengths of the first and second arm members;and a second assembly having a third pair of third arm members pivotallycoupled to a fourth pair of fourth arm members at a third link and afourth link, wherein the third arm members are coupled together at athird joint and the fourth arm members are coupled together at a fourthjoint, the second assembly having a low-profile delivery configurationand an expanded deployed configuration such that the third and fourthlinks are spaced laterally apart from each other by lengths of the thirdand fourth arm members, wherein the first and second assemblies in thedeployed configuration are configured to clamp native valve leafletsand/or a native annulus therebetween; wherein each of the first armmembers and each of the second arm members have a first curved edge anda second curved edge; and wherein, in the expanded deployedconfiguration, the first assembly and the second assembly form a curvedstructure configured to approximate a peripheral portion of the nativeannulus.